Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01423032

Enrollment

Registered

2011-08-25

Start date

2001-09-30

Completion date

2009-05-31

Last updated

2011-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

relapsed

Brief summary

Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine. Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.

Interventions

DRUGbendamustine

100 mg/m² iv, day 1+2, q4w

DRUGFludarabine

25 mg/m² iv, days 1-5, q4w

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* histologically or immunologically confirmed chronic B-cell leukemia * refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen * disease stage II-IV according to Rai or B/C according to Binet staging system, respectively * Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better * negative pregnancy test/ adequate method of contraception

Exclusion criteria

* T-CLL, PLL (prolymphocytic leukemia) * presence of Richter's transformation * first-line treatment containing either fludarabine or bendamustine * acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin \> 5mg/dl), renal system (creatinine \> 2 mg/dl), or metabolic disorders * secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)

Design outcomes

Primary

Measure	Time frame	Description
progression-free survival	the patients were followed on average for 36 months	individual time-frame up to max. follow-up (Kaplan-Meier estimation)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026